Quotient Sciences, an integrated CRDMO (Contract Research, Development and Manufacturing Organisation), has extended commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare disease affecting fewer than 1,000 people worldwide.
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This collaboration reinforces Quotient Sciences’ commitment to supporting the manufacture of niche and smaller volume commercial products often overlooked by larger CDMOs. Sohonos (Palovarotene), approved by the FDA in 2023, is a highly potent molecule which requires specialised handling and containment to protect both the facility and manufacturing operators.
As part of the partnership, Ipsen has invested in new equipment at Quotient Sciences’ Boothwyn, PA facility, including a Pneumatic Closed Transfer System, which ensures safe material transfer without impacting blend segregation, and a Flexible Dispensing Isolator, which enhances operator safety and eliminates special cleaning requirements. Quotient Sciences brings a world-class facility, an experienced team, reliable supply capabilities, and the ability to manage global shipments, ensuring seamless delivery and operational excellence throughout the partnership.
These additions expand Quotient Sciences’ capabilities for handling and manufacturing highly potent API (HPAPI) drug molecules and products, with known OELs at or below 1 µg/m³, while enabling seamless integration with existing equipment.
The partnership will ensure sustained commercial supply for FOP therapy and broaden capabilities to handle multiple highly potent compounds at commercial scale, addressing critical needs in rare disease treatment.
Marlene Leuenberger, VP and general manager, Quotient Sciences, Philadelphia commented: “This significant investment in advanced containment and manufacturing technology at our Boothwyn facility underscores Quotient Sciences’ unwavering commitment to supporting patients with ultra-rare diseases. By expanding our capabilities in handling highly potent compounds, we are not only ensuring a reliable supply of critical therapies like Sohonos (Palovarotene) for the FOP community, but also reinforcing our promise to deliver flexible, high-quality solutions for our partners with specialized needs especially for highly potent compounds.”